| CTRI Number |
CTRI/2025/03/081526 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF BREATHING ON MODIFIED MALLAMPATTI SCORE ON PREDICTING DIFFICULT AIRWAY- A PROSPECTIVE OBSERVATIONAL STUDY |
|
Scientific Title of Study
|
EFFECT OF BREATHING ON MODIFIED MALLAMPATTI SCORE AND ITS CORRELATION ON PREDICTING DIFFICULT AIRWAY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanush Kumble |
| Designation |
Postgraduate |
| Affiliation |
K S Hegde Medical Academy Deralakatte Mangaluru |
| Address |
Department of Anaesthesia and Operation Theatre Technology
K S Hegde Medical Academy Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7899075246 |
| Fax |
|
| Email |
dhanushkumble174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murali Shankar Bhat |
| Designation |
Associate Professor |
| Affiliation |
K S Hegde Medical Academy Deralakatte Mangaluru |
| Address |
Department of Anaesthesiology K S Hegde Medical Academy Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8884537753 |
| Fax |
|
| Email |
muralishankarbhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhanush Kumble |
| Designation |
Postgraduate |
| Affiliation |
K S Hegde Medical Academy Deralakatte Mangaluru |
| Address |
Department of Anaesthesia and Operation Theatre Technology
K S Hegde Medical Academy Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7899075246 |
| Fax |
|
| Email |
dhanushkumble174@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Deralakatte, Mangaluru - 575018 |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte Mangaluru 575018 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Murali Shankar Bhat |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
8884537753
muralishankarbhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KSHEMA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients more than or equal to 18 years undergoing general anaesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
patients with anticipated difficult airway, pregnancy. patient refusal, uncooperative patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| observe the changes in modified mallampati score on deep inspiration and deep expiration and its effect on predicting difficult airway |
2days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing changes in modified mallampatti score deep inspiration & expiration with Cormack Lehane grading for predicting difficult airway |
2days |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Modified mallampati score changes on deep inspiration and deep expiration, and their corresponding predictive accuracy. |